K143035 is an FDA 510(k) clearance for the Flight 60 Ventilator. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Flight Medical Innovations , Ltd. (Lod, IL). The FDA issued a Cleared decision on March 30, 2016, 525 days after receiving the submission on October 22, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K143035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2014 |
| Decision Date | March 30, 2016 |
| Days to Decision | 525 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK - Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |